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A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase

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ClinicalTrials.gov Identifier: NCT02369653
Recruitment Status : Recruiting
First Posted : February 24, 2015
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling)

Condition or disease Intervention/treatment Phase
Lymphoma Acute Lymphoblastic Leukemia Drug: Apixaban Other: No systemic anticoagulant prophylaxis Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention Versus No Systemic Anticoagulant Prophylaxis During Induction Chemotherapy in Children With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B Cell) Treated With Asparaginase
Actual Study Start Date : April 9, 2015
Estimated Primary Completion Date : May 28, 2020
Estimated Study Completion Date : May 28, 2020


Arm Intervention/treatment
Experimental: Apixaban

Children aged 1 to <18 years weighing 6 to <35 kg randomized to apixaban will receive a fixed dose apixaban based on body weight tier twice a day for approximately 28 days.

Children aged 1 to <18 years weighing ≥ 35 kg will receive 2.5 mg of apixaban twice a day for approximately 28 days. Subjects ≥ 5 years may be administered either 2.5-mg, 0.5-mg tablets or oral solution apixaban. Subjects < 5years and < 35 kg may be administered 0.5-mg tablets only

Drug: Apixaban
Placebo Comparator: No systemic anticoagulant prophylaxis
No systemic anticoagulant prophylaxis
Other: No systemic anticoagulant prophylaxis



Primary Outcome Measures :
  1. Efficacy: A composite of adjudicated non-fatal deep vein thrombosis (DVT, including asymptomatic and symptomatic), pulmonary embolism (PE), and cerebral venous sinus thrombosis (CSVT) and venous thromboembolism (VTE)-related-death [ Time Frame: Up to 1 month ]
    Objectively confirmed by independent adjudication

  2. Safety: Adjudicated major bleeding using the International Society on Thrombosis and Haemostasis (ISTH) definition for children [ Time Frame: Up to 1 month ]

Secondary Outcome Measures :
  1. Efficacy: a) Non-fatal asymptomatic DVT [ Time Frame: Up to 1 month ]
  2. Efficacy: b) Non-fatal symptomatic DVT [ Time Frame: Up to 1 month ]
  3. Efficacy: c) Non-fatal PE [ Time Frame: Up to 1 month ]
  4. Efficacy: d) CSVT [ Time Frame: Up to 1 month ]
  5. Efficacy: e) VTE-related-death [ Time Frame: Up to 1 month ]
  6. Safety: Composite of major and clinically relevant non major bleeding (CRNMB) using the ISTH definition for children [ Time Frame: Up to 1 month ]
  7. Pharmacodynamics: Anti-FXa Activity measured by plasma concentration assay [ Time Frame: Up to 1 month ]
  8. Pharmacokinetics: Measured by maximum observed concentration (Cmax) [ Time Frame: Up to 1 month ]
  9. Pharmacokinetics: Measured by trough observed concentration (Cmin) [ Time Frame: Up to 1 month ]
  10. Pharmacokinetics: Measured by area under the concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Up to 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • New diagnosis of de novo ALL, lymphomas (T or B cell), or mixed-phenotype acute leukemia
  • Planned 3-4 drug systemic induction chemotherapy with a corticosteroid, vincristine and a single dose or multiple doses of asparaginase, with or without daunorubicin
  • Functioning Central Venous Access Device
  • Must be able to tolerate oral medication or have it administered via an Nasogastric tube (NGT) or GT tube
  • Males and females,age 1 year(365 days) to < 18 (17 years and 364 days) years.

Exclusion Criteria:

  • Subjects scheduled to have > 3 Lumbar Punctures over the course of the study treatment period
  • Prior history of documented DVT or PE in the past 3 months
  • Known inherited bleeding disorder or coagulopathy
  • Major surgery [excluding Central Venous Access Device (CVAD) replacement and bone marrow aspiration and non-open biopsy] within the last 7 days prior to enrollment that may be associated with a risk of bleeding. Open biopsy is considered a major surgery.
  • Uncontrolled severe hypertension at enrollment. Severe hypertension is defined as a systolic or diastolic blood pressure (BP) > 5 mm Hg above the 95th percentile as defined by the National High Blood Pressure Education Program Working Group (NHBPEP) established guidelines for the definition of normal and elevated blood pressure in children
  • Extreme hyperleukocytosis, white blood cell (WBC) counts over 200 x 109/L (200,000/microL) at the time of enrollment
  • Liver dysfunction manifested by SGTP (ALT) > 5X Upper limit of normal (ULN) and/or Aspartate aminotransferase (AST) >5 X ULN and/or direct (conjugated) bilirubin > 2X ULN
  • Renal function < 30% of normal for age and size as determined by the Schwartz formula
  • International normalized ratio (INR) > 1.4 and activated partial thromboplastin time (aPTT) > 3 seconds above the upper limit of normal for age, within 1 week prior to enrollment.
  • History of allergy to apixaban or Factor Xa inhibitors
  • History of significant adverse reaction or major bleeding related adverse reaction to other anticoagulant or antiplatelet agents
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity
  • Any investigational drug being administered during the study

Other protocol inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369653


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

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Locations
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United States, Arizona
Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr. Recruiting
Phoenix, Arizona, United States, 85016
Contact: Jessica Boklan, Site 0027    602-546-0188      
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Weili Sun, Site 0097         
Loma Linda University Cancer Center Recruiting
Loma Linda, California, United States, 92350
Contact: Albert Kheradpour, Site 0009    909-558-7146      
Childrens Hospital Of La Recruiting
Los Angeles, California, United States, 90027
Contact: David Freyer, Site 0010    323-361-5973      
Local Institution Not yet recruiting
Los Angeles, California, United States, 90027
Contact: Site 0013         
Local Institution Not yet recruiting
Orange, California, United States, 92868
Contact: Site 0003         
Rady Children'S Hospital - San Diego Recruiting
San Diego, California, United States, 92123-4282
Contact: Hilda Ding, Site 0096         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael Isakoff, Site 0076    860-545-9614      
United States, Delaware
Nemours / A. I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Emi Caywood, Site 0062    302-651-5763      
United States, Florida
Golisano Childrens Hospital of Southwest Florida Completed
Fort Myers, Florida, United States, 33908
Nemours Children'S Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Scott Bradfield, Site 0002    904-697-2508      
Nemours Children'S Clinic-Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Jeffrey Schwartz, Site 0058    850-505-4794      
All Childrens Hospital Specialty Physicians Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Peter Shaw, Site 0014    727-767-4784      
Local Institution Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Site 0099         
St. Marys Medical Center Completed
West Palm Beach, Florida, United States, 33407
United States, Georgia
Childrens Healthcare Of Atlanta - E Recruiting
Atlanta, Georgia, United States, 30342
Contact: Glen Lew, Site 0008    404-785-4746      
United States, Idaho
St. Luke'S Mountain State Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Eugenia Chang, Site 0080    208-381-2711      
United States, Indiana
Children'S Center For Cancer And Blood Diseases Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Douglas Cipkala, Site 0098         
United States, Iowa
Blank Childrens Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Wendy Woods-Swafford, Site 0052    515-241-8912      
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mariko Sato, Site 0029         
United States, Kentucky
University Of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Ashok Raj, Site 0033    502-629-7180      
United States, Louisiana
Childrens Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Lolie Yu, Site 0018    504-896-9740      
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Craig Lotterman, Site 0066    504-842-3903      
United States, Maryland
Sinai Hospital Of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Jason Fixler, Site 0079    410-601-8393      
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21231
Contact: Patrick Brown, Site 0025    410-955-0432      
United States, Michigan
University Of Michigan Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-5718
Contact: Steven Pipe, Site 0044    734-763-6344      
Local Institution Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Site 0070         
United States, Minnesota
Childrens Hospitals And Clinics Of Minnesota Completed
Minneapolis, Minnesota, United States, 55404
University Of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Peter Gordon, Site 0007         
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Vilmarie Rodriguez, Site 0055    507-284-2511      
United States, Mississippi
University Of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Gail Megason, Site 0004    601-984-5220      
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Frances Flug, Site 0020    201-487-8987      
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Richard Drachtman, Site 0061    732-235-7898      
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Alexander Gozman, Site 0091    518-262-5513      
Local Institution Not yet recruiting
Bronx, New York, United States, 10467
Contact: Site 0126         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Barbara Bambach, Site 0035    716-845-4561      
University Of Rochester General Clinical Research Center Recruiting
Rochester, New York, United States, 14642
Contact: Angela Girvin, Site 0064    585-275-5839      
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Jessica Hochberg, Site 0050    914-594-2132      
United States, North Carolina
Unv. Of Nc At Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Stuart Gold, Site 0031    919-966-0987      
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Thomas Russell, Site 0043    336-716-9027      
United States, Ohio
Akron Children'S Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Steven Kuerbitz, Site 0019    330-543-8731      
Local Institution Not yet recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Site 0110         
University Hospitals Recruiting
Cleveland, Ohio, United States, 44106
Contact: Sanjay Ahuja, Site 0092         
Nationwide Children'S Hospital Recruiting
Columbus, Ohio, United States, 43205-2664
Contact: Mark Ranalli, Site 0001    614-722-3694      
United States, Oregon
Local Institution Not yet recruiting
Portland, Oregon, United States, 97227
Contact: Site 0005         
United States, Pennsylvania
Lehigh Valley Hospital - Muhleberg Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Lydia Alberta Boateng, Site 0087    484-884-3166      
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822-1320
Contact: Jagadeesh Ramdas, Site 0063    570-271-6896      
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Lisa Mcgregor, Site 0015    717-531-3097      
Childrens Hospital Of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Leonard Bailey, Site 0016    215-590-2801      
Children's Hospital Of Pittsburgh Of UPMC Completed
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Children's Hospital at TriStar Centennial Recruiting
Nashville, Tennessee, United States, 37203
Contact: Haydar Frangoul, Site 0104         
Monroe Carell Jr Children'S Hosp. At Vanderbilt Tower Recruiting
Nashville, Tennessee, United States, 37232-6310
Contact: Adam Esbenshade, Site 0060    615-936-1762      
United States, Texas
Dell Children'S Medical Center Of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Virginia Harrod, Site 0083    512-628-1902      
Driscoll Children'S Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Nkechi Mba, Site 0105         
Texas Children's Cancer and Hematology Centers Recruiting
Houston, Texas, United States, 77030
Contact: Julienne Brackett, Site 0021    713-798-1354      
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Timothy Griffin, Site 0077    210-704-4275      
University Hospital Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Anne-Marie Langevin, Site 0054    210-562-9025      
Local Institution Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Site 0030         
Scott & White - McLane Children's Specialty Clinic Completed
Temple, Texas, United States, 76502
United States, Virginia
Local Institution Not yet recruiting
Richmond, Virginia, United States, 23298
Contact: Site 0093         
United States, Washington
Providence Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99204
Contact: Judy Felgenhauer, Site 0040    509-474-2777      
MultiCare Institute for Research & Innovation Recruiting
Tacoma, Washington, United States, 98405
Contact: Robert Irwin, Site 0078    253-403-3321      
United States, Wisconsin
Medical College Of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Paul Harker-Murray, Site 0090    414-955-4170      
Australia, New South Wales
Local Institution Terminated
New Lambton Heights, New South Wales, Australia, 2305
Australia, Queensland
Lady Cilento Children's Hospital Completed
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Monash Medical Centre Clayton Completed
Clayton, Victoria, Australia, 3168
Local Institution Completed
Parkville, Victoria, Australia, 3052
Belgium
Local Institution Not yet recruiting
Bruxelles, Belgium, 1200
Contact: Site 0127         
Local Institution Not yet recruiting
Leuven, Belgium, 3000
Contact: Site 0130         
Canada, Alberta
Alberta Children'S Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Victor Lewis, Site 0049    4039557272      
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Site 0107         
Canada, Newfoundland and Labrador
Local Institution Not yet recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Site 0094         
Canada, Ontario
Children'S Hospital London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Shayna Zelcer, Site 0053    519685850055231      
Children'S Hospital Of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Donna Johnston, Site 0048    61373776003783      
Korea, Republic of
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 03080
Contact: Site 0118         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 03722
Contact: Site 0119         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02369653     History of Changes
Other Study ID Numbers: CV185-155
2014-000328-47 ( EudraCT Number )
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

Keywords provided by Bristol-Myers Squibb:
Anticoagulation

Additional relevant MeSH terms:
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Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Apixaban
Anticoagulants
Asparaginase
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents